FDA pushes back on silicone breast implant study

The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks despite – despite granting approvals to a slew of the implants in recent years.

The study, published Sept. 14 in the Annals of Surgery, looked at data from nearly 100,000 breast implant procedures the researchers gleaned from FDA-mandated post-approval studies for implants made by Johnson & Johnson (NYSE:JNJ) unit Mentor and by Allergan (NYSE: AGN). The analysis showed that silicone implants are associated with higher rates of Sjögren syndrome, scleroderma , rheumatoid arthritis, stillbirth and melanoma. There was one reported case of BIA-ALCL and no association with suicide.

The risk of rupture over the short term was higher for saline implants at 2.5%, compared with0.5% for silicone implants, but capsular contracture for the silicone implants was 5.0% compared with 2.8% for saline-filled implants.

“Silicone implants are associated with an increased risk of certain rare harms; associations need to be further analyzed with patient-level data to provide conclusive evidence. Long-term safety and implant-related outcomes should inform patient and surgeon decision-making when selecting implants,” the researchers wrote.

In an editorial published alongside the study results, Dr. Binita Ashar, director of surgical devices at the bureau’s Center for Devices & Radiological Health, said the results should be taken with a grain of salt.

“Unfortunately, as the authors acknowledge, they failed to account for methodologic [sic] differences between studies, inconsistencies in the data, differential loss to follow-up, confounding and other potential sources of bias. Because of these significant methodological shortcomings, the reports conclusions should be viewed with caution,” Ashar wrote. “Moreover, the limitations of this report highlight the need for better postmarket evidence generation, including active surveillance capabilities. This is why FDA has helped develop breast implant registries and is working with other partners to establish the National Evaluation System for health Technology.”

“We understand that there are concerned patients with breast implants who are experiencing a range of symptoms that may or may not be related to their breast implants. We take these concerns seriously and are committed to continuing to work with patient groups, surgeons and scientists to further assess this issue. While the agency continues to believe that the weight of the currently available scientific evidence does not conclusively demonstrate an association between breast implants and connective tissue diseases, we respect studies like the ones published in Annals of Surgery by our peers. These studies contribute to our discourse on this topic, but more evaluation is required,” Ashar added in a separate statement.

Breast implants have been at the center of growing public outcry since the 1980s; in 1992 to FDA halted sales of silicone-filled implants pending further study, but let them back on the market in 2006. In 2011, an agency review warned of a possible link between saline- and silicone gel-filled implants and anaplastic large-cell lymphoma. That June the FDA warned that gel-filled implants often cause complications that need additional surgery or removal. Consumer groups asked the safety watchdog to recall the devices, on the grounds that implant makers hadn’t kept up with promises to collect post-market data, but the FDA determined that a lack of long-term data was not reason enough to issue a recall.

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